(Total Views: 543)
Posted On: 03/12/2021 1:41:44 PM
Post# of 154888
Very happy to see this board up and running again. There's so much intelligent commentary here. Ihub is a cesspool, and yahoo has just been crawling with shorts for over a year now. Very tiresome.
I might have been wearing my rose colored glasses during the conference call, but my impression of the EUA situation is that they had conferred with several people, including a former FDA statistician, and felt that they had enough to file for EUA while continuing on with CD16 for full approval.
Ideally, to me at least, the best option would be a phase 4 with additional data monitoring, rather than a phase 3 with a placebo group. But if the phase 3 is required, hopefully they can enroll quickly, and have it nearly filled before any response to an EUA comes down. EUA's have been taking about 30 days for consideration.
The fact that the FDA granted an EUA for Dexa with age stratified data, and the fact that other covid drugs have been approved using secondary endpoints, makes me hopeful that we will get approval sooner rather than later.
I might have been wearing my rose colored glasses during the conference call, but my impression of the EUA situation is that they had conferred with several people, including a former FDA statistician, and felt that they had enough to file for EUA while continuing on with CD16 for full approval.
Ideally, to me at least, the best option would be a phase 4 with additional data monitoring, rather than a phase 3 with a placebo group. But if the phase 3 is required, hopefully they can enroll quickly, and have it nearly filled before any response to an EUA comes down. EUA's have been taking about 30 days for consideration.
The fact that the FDA granted an EUA for Dexa with age stratified data, and the fact that other covid drugs have been approved using secondary endpoints, makes me hopeful that we will get approval sooner rather than later.
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